Dune Medical Devices has completed patient enrollment in the MarginProbe pivotal clinical trial. The MarginProbe procedure provides surgeons with real-time detection of cancer at the edges of the tissue removed during breast conservation surgery (BCS), to ensure complete removal of tumor from the breast.
The randomized, controlled trial includes 664 women who underwent BCS at one of 21 major medical facilities, with 18 in the US and three in Israel. The real-time, cancer detection procedure is designed to give surgeons a simple, instant indication of the presence of cancer at the margins, allowing for its immediate removal.
The company claims that the main surgical objective of BCS is the removal of the primary tumor with a rim of healthy tissue, known as the margin, preferably in one surgical session. According to the medical literature, between 20% and 40% of BCS patients require a second surgery because clear margins were not achieved during the initial procedure.
Lorraine Tafra, lead investigator, medical director of Anne Arundel Breast Center, Annapolis, said: “This trial is one of the largest randomized, controlled trials for intraoperative margin assessment ever undertaken. Completing enrollment in 15 months is an accomplishment.
“Because of the importance of achieving clear margins in BCS and the potential of MarginProbe to improve upon existing standards, we eagerly anticipate the trial results. Such a rigorous trial has the potential to help us in the development of better breast surgery techniques.”
Dan Hashimshony, founder and CEO of Dune Medical Devices, said: “This is a significant milestone in our mission to reduce the need for multiple surgeries to treat breast cancer. The intent of this trial was to obtain a rigorous and ample body of data that demonstrates the capacity of our technology to improve surgical oncology practice and outcomes. We are grateful to everybody involved in this significant clinical trial, including physicians, nurses, staff, and especially the patients.”